Many techniques can be employed in order to simplify formal verification testing. These techniques expedite the product development process and reduce cost. During verification planning, the required sample size (and therefore the number of devices that need to be built prior to production), can be minimized by the choice of verification method.
You may not be able to tell a book by its cover, but resolutions offer a peek into individual plans and priorities. When combined, they even offer a glimpse of company culture. Our employees share their 2022 resolutions as inspiration and an invitation for kindred spirits to join us in the new year!
Artificial intelligence (AI) and machine learning (ML) technologies have a huge potential to change the way we look at our current health care practices. AI/ML enable new insights derived from the huge amount of data that is collected every day in the health care sector. This blog provides an overview of the FDA action plan for AI/ML in software as a medical device and lists some best practices.
Let’s talk about what an anodized finish actually is.
A core finishing technique around the world, anodizing is highly valued in the medical industry to promote longevity of devices. It is a finishing process that can be applied to a few different materials, the most common being aluminum (in fact, this blog will only discuss aluminum anodizing).
“I often think of reading books as a means to create a worldview. I want to know what the world looks like today, how we got here and how we can do better tomorrow. The world opportunities and challenges are infinite. It is a gigantic puzzle. That being said, in 2020, I tried to diversify my readings toward creating a big picture of the world – from leadership to technology, retirement, empowerment, society, education, data and startups. Here are 8 of the books I read in 2020.
Our content team took Arash’s idea and offer up fifteen favorite reads from 2021. In no particular order, their selections cover business, fiction, biographies, self-improvement and create a StarFish worldview.
Our 2021 top 10 medical device commercialization videos include 4 new videos. They join favorites from previous years and cover topical and perennial subjects including 2021 updates, optimizing founder value, manufacturing for NPI and IVD insights.
The word innovation is often thrown around like many other business buzzwords. Real medical device innovation takes effort and is truly valuable. Here are a few key ingredients that will improve the odds of achieving this elusive goal.
Two new medical device commercialization blogs, one returning champion, and two new authors join our 2021 “most read” list. Electrical engineering amd regulatory articles tie for the most popular blog topics. Many thanks to our employee authors past and present for sharing their insights and experience with medical device colleagues.
Part 2: Incident Irradiance, Exposure, Gain, and Frame Rate
Camera sensors are common components of medical devices. In this blog I will discuss in detail how incident light irradiance, exposure time, gain, and frame rate factor into the use of camera sensors for medical devices.
Discover Strategic Sourcing, Exit Value, and Timing lessons learned from engineers, NPI (New Product Introduction) experts, manufacturing, and senior managers with 20 plus years of medical device NPI commercialization design, development, and manufacturing.
In my experience, a product’s best chance at successful commercialization is to ensure it follows a Five Step Development process. Company value, and user safety will rely on the due diligence required within each step of the process. The engineers who develop these frameworks live and breathe Murphy’s epigram, “Anything that can go wrong will go wrong”. Your investors and customers will thank you.
Recently we conducted pre-testing (testing done in-house to increase confidence before undertaking more expensive formal testing) for ISO 18562-2:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 2: Tests for emissions of particulate matter is an ISO standard for particulate testing in breathing gas pathways. This is a sub-standard of the larger ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part 1: Evaluation and testing within a risk management process standard. In this blog I will share our approach from my engineering perspective.